New PhIII data raises hopes for Celgene's apremilast

Celgene has unveiled late-stage data showing that its experimental drug apremilast induced "meaningful improvements" in the signs and symptoms of psoriatic arthritis in the long term, adding further weight to the package of data being used to seek regulatory approval.

Phase III data, presented at the European Congress of Rheumatology (EULAR) annual meeting in Spain, showed that after 52 weeks of treatment with apremilast 63% of patients receiving the 20mg twice daily dose and 55% taking 30mg twice daily achieved at least a 20% reduction in the signs and symptoms of the disease.

Similar improvements over time were also observed in the ACR 50 and ACR 70 scores, the firm said.

In addition, the safety and and tolerability profile of the drug during the 52-week treatment period was consistent with that seen in the placebo arm of the trial (0-24 weeks) and in other trials to date, according to Celgene.

The firm also noted there were no safety signals with respect to major cardiac events, malignancies, including lymphoma or systemic opportunistic infections, and no cases of reactivations of tuberculosis were reported. Most common side-effects were included nausea, diarrhoea, headache, URTI and nasopharyngitis.

Up to 30% of people with psoriasis eventually develop psoriatic arthritis, a chronic disorder with progressive and additive joint inflammation that can impact on quality of life and work disability.

Unmet need

And yet, there remains a “a high unmet medical need for additional efficacious, well-tolerated treatment options for patients," with the condition, commented Arthur Kavanaugh, Professor of Clinical Medicine and Director of the Center for Innovative Therapy at the University of California, San Diego School of Medicine.

The company has filed the drug for psoriatic arthritis in the US and Canada, and plans a combined psoriatic arthritis/psoriasis submission in Europe in the second half of this year.

Celgene is expecting the drug to eventually pull in sales of around $2 billion, though some analysts still feel this is on the optimistic side, according to media reports.